Experimental CAR t therapy targets Hard-to-Treat cancers in first human trial
NCT ID NCT05568680
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study is testing a new treatment called SynKIR-110 for people with advanced ovarian cancer, bile duct cancer, or mesothelioma that has spread or come back. The treatment involves taking a patient's own immune cells, engineering them in a lab to better recognize and attack cancer cells that have a protein called mesothelin, and then giving them back as a one-time infusion. The main goals are to see if it is safe and feasible, and to find the best dose for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SynKIR-110 (a type of CAR T cell therapy made from the patient's own immune cells, engineered to target mesothelin on cancer cells)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced ovarian cancer, bile duct cancer, or mesothelioma that has not responded to standard therapies.
- What could go wrong
- This is a very early (Phase 1) trial with only 42 participants, so it is primarily testing safety, not effectiveness. The therapy may cause serious side effects like cytokine release syndrome or nerve problems, and it may not shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease * Adult 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma. * Satisfactory Blood coagulation parameters * Satisfactory organ and bone marrow function Exclusion Criteria: * Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years. * History of T or B cell malignancies or previous gene-engineered T cell therapies. * Sarcomatoid/biphasic mesothelioma. * Pulmonary exclusions * Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease * Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening * Active autoimmune disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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University of Kansas Cancer Center
ACTIVE_NOT_RECRUITINGWestwood, Kansas, 66205, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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University of Wisconsin Carbone Cancer Center
RECRUITINGMadison, Wisconsin, 53792, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?
- New antibody aims to preserve immune checkpoint while fighting cancer